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1.
Int J Pharm ; 496(2): 421-31, 2015 Dec 30.
Article in English | MEDLINE | ID: mdl-26456268

ABSTRACT

A newly licensed biosimilar product containing infliximab as the active pharmaceutical ingredient has recently been marketed under the brand name Remsima®. We have evaluated the stability of Remsima® diluted in sodium chloride solution and stored in polyolefin bags at 2-8°C using a range of techniques to assess the physico-chemical and functional integrity of the drug over time. The methods and techniques employed are fully compliant with NHS (UK) guidance for evaluating the stability of biologicals, enabling the data to be used for the application of an extended shelf-life to Remsima products in the UK, when prepared under a Section 10 exemption or a Specials Licence. The results clearly demonstrate physico-chemical and functional stability of the drug over the 7 day period of the study, when prepared as described here under aseptic conditions in accordance with the Summary of manufacturers Product Characteristics.


Subject(s)
Antibodies, Monoclonal/chemistry , Cell Line , Chromatography, High Pressure Liquid , Drug Stability , Drug Storage , Dynamic Light Scattering , Guideline Adherence , Humans , Hydrogen-Ion Concentration , Protein Structure, Secondary , United Kingdom
2.
AACN Adv Crit Care ; 19(1): 59-65, 2008.
Article in English | MEDLINE | ID: mdl-18418106

ABSTRACT

Educating nurses for the healthcare delivery workforce is stymied as qualified applicants to nursing programs are being turned away. Although applications to baccalaureate programs have increased, between 41,683 and 147,000 undergraduate and graduate applicants were turned away from nursing education programs in 2005 due largely to shortages of nursing faculty. In this article, the evidence-based rationale for the development of a dual-certification program for the preparation of clinical nurse specialists and nurse educators is described. Because faculty shortages are nationwide, we developed the program to be delivered, in its entirety, online. Standardized data collection methods for evaluating student progress and their achievement of competencies expected of clinical nurse specialists and nurse educators are provided. The program may be a model for preparing clinically competent nurse educators who prefer practice settings to full-time faculty positions.


Subject(s)
Certification , Computer-Assisted Instruction/methods , Education, Nursing, Graduate/methods , Faculty, Nursing , Models, Educational , Clinical Competence/standards , Faculty, Nursing/supply & distribution , Humans , Illinois , Internet , Nursing Education Research , Program Evaluation
3.
AACN Adv Crit Care ; 19(1): 85-97, 2008.
Article in English | MEDLINE | ID: mdl-18418109

ABSTRACT

Vacancy rates of nursing faculty are on the increase as fewer educators are being prepared and nurses at the bedside are in short supply. Advanced practice nurses--uniquely suited to provide clinical education for undergraduate and graduate students--are underutilized. However, without release time, preparation as educators, ongoing support from education and administration, and remuneration for providing both evidence-based education and evidence-based patient care, they can hardly be expected to assume additional responsibilities. This article reviews academic-service partnerships, noting a general lack of published efficacy and cost-effectiveness data, and highlights 21st-century innovations for academia and service to share resources for the benefit of all stakeholders--especially patients and students.


Subject(s)
Cooperative Behavior , Critical Care , Faculty, Nursing/supply & distribution , Nursing Faculty Practice/organization & administration , Schools, Nursing/organization & administration , Evidence-Based Medicine , Health Services Needs and Demand , Humans , Interinstitutional Relations , Models, Nursing , Models, Organizational , Nursing Evaluation Research , Organizational Objectives
4.
AACN Adv Crit Care ; 18(1): 45-58; quiz 59-60, 2007.
Article in English | MEDLINE | ID: mdl-17284947

ABSTRACT

Dyspnea is a common symptom in patients with acute and chronic critical illness as well as in patients receiving palliative care. While dyspnea can be found in a variety of clinical arenas and across many specialties, the mechanisms that cause dyspnea are similar. Although not often the cause for admission to critical care, it may complicate and extend length of stay. This article defines and describes dyspnea and its pathophysiology. Critical care nurses should strive to implement interventions supported by evidence whenever possible. An evidence-based plan of care for the assessment, planning, intervention, and evaluation of the patient with dyspnea is outlined, using levels of recommendation based on the strength of available evidence. Two case studies are presented to illustrate its application to clinical practice.


Subject(s)
Critical Care/methods , Dyspnea/therapy , Evidence-Based Medicine/methods , Nursing Assessment/methods , Patient Care Planning/organization & administration , Adult , Aged , Chemoreceptor Cells/physiopathology , Dyspnea/diagnosis , Dyspnea/etiology , Female , Humans , Male , Mechanoreceptors/physiopathology , Nurse's Role , Oxygen Inhalation Therapy/nursing , Palliative Care/methods , Physical Examination , Research Design , Respiration, Artificial/nursing , Risk Factors , Severity of Illness Index
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